JP5930473B2 - Use of stimulation pulse shapes to control nerve recovery commands and clinical effects - Google Patents

Use of stimulation pulse shapes to control nerve recovery commands and clinical effects Download PDF

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JP5930473B2
JP5930473B2 JP2013114262A JP2013114262A JP5930473B2 JP 5930473 B2 JP5930473 B2 JP 5930473B2 JP 2013114262 A JP2013114262 A JP 2013114262A JP 2013114262 A JP2013114262 A JP 2013114262A JP 5930473 B2 JP5930473 B2 JP 5930473B2
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pulse
electrical
stimulation
nerve stimulation
pulse shape
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JP2013163112A (en
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ドンチュル リー
ドンチュル リー
マイケル アダム モフィット
マイケル アダム モフィット
クリストファー ユアン ギレスピー
クリストファー ユアン ギレスピー
ケリー ブラッドレー
ケリー ブラッドレー
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ボストン サイエンティフィック ニューロモデュレイション コーポレイション
ボストン サイエンティフィック ニューロモデュレイション コーポレイション
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36146Control systems specified by the stimulation parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36017External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36135Control systems using physiological parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
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    • A61N1/37247User interfaces, e.g. input or presentation means
    • AHUMAN NECESSITIES
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    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • AHUMAN NECESSITIES
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    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • AHUMAN NECESSITIES
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    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye
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    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3906Heart defibrillators characterised by the form of the shockwave

Description

  The present invention relates to a tissue stimulation system, and more particularly to a system and method for adjusting the stimulation applied to tissue to maximize the therapeutic effect.

  Implantable neural stimulation systems have proven therapeutic efficacy in a wide range of diseases and disorders. Pacemakers and implantable defibrillators (ICDs) have been shown to be highly effective in the treatment of many heart diseases (eg, arrhythmias). Spinal cord stimulation (SCS) systems have been accepted as a therapeutic strategy for the treatment of chronic disease syndromes, and the use of tissue stimulation has begun to expand to other applications such as angina and incontinence. Deep brain stimulation (DBS) has also been used as a treatment for over 10 years in the treatment of refractory Parkinson's disease and has recently been used in other areas such as true tremor and epilepsy. In addition, recent studies have shown that the peripheral nerve stimulation (PNS) system is effective in treating chronic disease syndromes and incontinence, and many other applications have been recently studied. In addition, functional electrical stimulation (FES) systems, such as the freehand system by NeuroControl (Cleveland, Ohio), have been applied to restore function for limb paralysis in patients with spinal cord injury.

  Each of these implantable neurostimulation systems is typically implanted at a desired stimulation site with a stimulation lead having one or more electrodes and implanted away from the stimulation site. A neural stimulation applicator coupled directly or indirectly to the stimulation lead via the lead. In this case, an electrical pulse is supplied from the neural stimulation applicator to the stimulation electrode, stimulating or activating a number of tissues according to the stimulation parameter settings and providing the patient with the desired effective treatment. Typical stimulation parameter settings can include the electrode that is the source (anode) or return (cathode) of the stimulation current at a given time, as well as the amplitude, duration, and pulse rate of the stimulation pulse. Ideally, the shape of the electrical pulses emitted by current neural stimulation systems is square, but often is shaped by both passive circuit components with non-linear electrical characteristics and biological tissue. The neural stimulation system can further include a handheld patient programmer that remotely commands the neural stimulation applicator to generate electrical stimulation pulses in accordance with selected stimulation parameters. A remote control (RC) form of a handheld programmer can itself be programmed by a clinician using, for example, a clinician programmer (CP), which is typically Can be a general-purpose computer, such as a laptop, with a program software package installed.

  Typically, therapeutic effects for problematic neural stimulation applications can be optimized by adjusting stimulation parameters. These therapeutic effects often correlate with the diameter of nerve fibers that stimulate many tissues to be stimulated. For example, in SCS, activation (ie, recovery) of large diameter sensory fibers reduces / prevents transmission of small diameter painful fibers through interneuron interactions in the dorsal horn of the spinal cord. it is conceivable that. The activation of large sensory fibers forms a sensation that can be characterized as an alternative sensation instead of the pain signal felt by the patient, and this sensation is known as sensory abnormalities. Therefore, large diameter nerve fibers have been considered the main purpose of SCS. However, excessive stimulation of large diameter nerve fibers can cause other unpleasant, intense sensations and side effects in unwanted areas, so the treatment range is limited in the case of SCS. . Therefore, control of nerve fiber recovery based on size is very important to maximize the therapeutic effect of SCS. The control of the command to recover nerve fibers of different sizes asynchronously (recovering nerve fibers at different times with a single pulse) as well as temporarily synchronized (recovering nerve fibers simultaneously with a single pulse) It is thought that the therapeutic effect of can be maximized.

  Thus, a neural stimulation system that selects and activates fibers of different diameters in a controllable manner is effective to “harmonize” the desired therapeutic effect of applying neural stimulation, such as SCS. Regardless of the ability to restore differently sized nerve fibers in a controlled manner, it is useful to provide additional stimulation parameters that can be adjusted to further maximize the therapeutic effect of the stimulation.

US Pat. No. 6,895,280 US Pat. No. 6,516,227 US Pat. No. 6,993,384 US Pat. No. 7,317,948 US Patent Application Publication No. 2007/0038250 US Patent Publication No. 2003/0139881 US Patent Publication No. 2005-0267546 US Pat. No. 6,393,325 US Pat. No. 6,909,917

  According to a first aspect of the invention, a method is provided for treating a patient. The method places one or more electrodes close to a patient's tissue (eg, spinal cord tissue), supplies electrical stimulation energy from the electrodes to the tissue according to a defined waveform, and forms a pulse shape of the waveform And thereby changing the characteristics of the electrical stimulation energy delivered from the electrode to the tissue.

  In one method, the pulse shape selects one of a plurality of different pulse shape types (eg, square pulse, exponential curve pulse, logarithmic curve pulse, tilt pulse, trapezoidal pulse, or combinations thereof). It is corrected by this. Different pulse types may include, for example, decreasing gradient pulses such as decreasing gradient exponential pulses or decreasing gradient linear ramp pulses, and increasing gradient pulses such as increasing gradient exponential pulses or increasing gradient linear ramp pulses. it can. In another method, the pulse shape is modified by adjusting the time constant of the pulse shape.

  The pulse shape and other pulse parameters (eg, pulse amplitude, pulse duration, and pulse rate) of the defined waveform can be modified independently of each other or in a manner dependent on each other. In the latter case, the effect of modifying at least one of the other pulse parameters in response to modification of the pulse shape to maintain a substantially uniform charge of electrical stimulation energy can be obtained. An optional method includes measuring one or more electrical properties (eg, impedance) of the tissue, where the pulse shape is modified based on the measured electrical properties. As an example, the pulse shape can be modified in response to changes in measured electrical properties.

  According to a second aspect of the present invention, a neural stimulation system is provided. The neural stimulation system includes one or more electrical terminals configured to couple with one or more stimulation leads, an output stimulus capable of outputting electrical stimulation energy to the electrical terminals according to a defined waveform And a control circuit configured to modify the pulse shape of the defined waveform and thereby change the characteristics of the electrical stimulation energy output to the electrical terminal. In one embodiment, the control circuit is configured to modify the pulse shape by selecting one of a plurality of different pulse shape types, for example, one of the different types of pulse shapes described above. . In another embodiment, the control circuit is configured to modify the pulse shape by adjusting a time constant of the pulse shape.

  The control circuit can be configured to modify the pulse shape and other pulse parameters of the defined waveform independently of each other or in a manner dependent on each other. In the latter case, the control circuit may be configured to modify at least one of the other parameters in response to the pulse shape modification to maintain a substantially uniform charge of electrical stimulation energy. it can. In any embodiment, the neural stimulation system further includes a monitor circuit configured to measure one or more electrical properties (eg, impedance) of the tissue, wherein the control circuit includes the measured electrical properties. To modify the pulse shape based on For example, the control circuit can be configured to modify the pulse shape in response to changes in one or more measured electrical characteristics.

  The pulse shape of the defined waveform can be modified in any one or more of a variety of ways. For example, the output stimulus circuit can be composed of a plurality of different analog shaping circuits, in which case the control circuit is configured to modify the pulse shape by selecting one of the different analog shaping circuits. be able to. The control circuit can also be configured to modify the pulse shape by adjusting the characteristics of at least one analog electrical component in the output stimulation circuit. In one embodiment, the pulsed waveform is formed by a stepped function of amplitude level or sub-pulse duration, in which case the control circuit modifies the pulse shape by adjusting the amplitude level or sub-pulse duration. It can be constituted as follows.

  In one embodiment, the neural stimulation system further includes a stimulation lead having at least one electrode electrically coupled to the electrical terminal. In another embodiment, the neural stimulation system further includes a memory capable of storing parameters that define the pulse shape. In yet another embodiment, the neural stimulation system includes a telemetry circuit that can wirelessly receive commands from an external programmer to modify the pulse shape. In yet another embodiment, the neural stimulation system includes a case that houses an electrical terminal, an output stimulation circuit, and a control circuit to form a neural stimulation applier (eg, an implantable neural stimulation applier).

  According to a third aspect of the invention, a neural stimulation applicator programmer is provided. A programmer is configured to generate a user interface capable of receiving input from a user, a plurality of stimulation parameter settings defining a plurality of different pulse shapes in response to the user input, And an output circuit configured to transmit the plurality of stimulation parameter settings to the neural stimulation applier. In one embodiment, the plurality of different pulse shapes includes a plurality of different types of pulse shapes, eg, any of the different types of pulse shapes described above. In another embodiment, the plurality of different pulse shapes include a plurality of pulse shapes that have different time constants but are of the same type (eg, exponential decaying pulse amplitude).

  The processor may be configured to determine the pulse shape and other pulse parameters at each stimulation parameter setting independently of each other or in a manner dependent on each other. In the latter case, the processor is configured to define at least one of the other pulse parameters in response to the setting of the pulse shape, maintaining a substantially uniform charge between the respective stimulation parameter settings. be able to. In one embodiment, the plurality of different pulse shapes may be applied to one or more measured electrical properties (eg, impedance) of the tissue, for example by defining the pulse shape in response to changes in the measured electrical properties. Determined based on. In another embodiment, the programmer can include a user interface that includes an actuator, in which case the processor responds to the activation of the actuator with a plurality of stimulation parameter settings (e.g., Different pulse shapes) can be generated. In yet another embodiment, the output circuit is a telemetry circuit capable of wirelessly transmitting a plurality of stimulation parameter settings to the neural stimulation applier.

  Other and further aspects and features of the present invention will become apparent upon reading the following detailed description of the preferred embodiments, which are intended to be illustrative of the invention and not limiting .

  The drawings illustrate the intent and utility of the preferred embodiments of the present invention, and like elements are denoted by common reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS In order that the above and other advantages and objectives of the present invention may be more appreciated, a more particular description of the present invention described above will be made with reference to specific embodiments illustrated in the accompanying drawings. I will explain it. With the understanding that these drawings depict only typical embodiments of the invention and are not to be considered as limiting the scope thereof, additional drawings may be used to identify The invention will be described with reference to details.

1 is a plan view of one embodiment of a spinal cord stimulation (SCS) system arranged in accordance with the present invention. FIG. FIG. 2 is a side view of an implantable pulse generator (IPG) used in the SCS system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 2 is a diagram of various stimulation pulse shapes that can be generated by the system of FIG. 1. FIG. 7 is a bar graph of the number of nerve fibers of 8.7 μm diameter that recover over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. 7 is a bar graph of the number of nerve fibers of 8.7 μm diameter that recover over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. 7 is a bar graph of the number of nerve fibers of 8.7 μm diameter that recover over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. 4 is a bar graph of the number of 11.5 μm diameter nerve fibers recovering over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. FIG. 4 is a bar graph of the number of 11.5 μm diameter nerve fibers recovering over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. FIG. 4 is a bar graph of the number of 11.5 μm diameter nerve fibers recovering over time corresponding to square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. FIG. In the figure of the recovery ratio by time of the total number of nerve fibers with a diameter of 8.7 μm versus the total number of nerve fibers with a diameter of 11.5 μm, corresponding to the application of square pulses, decreasing gradient exponential pulses and increasing gradient exponential curves is there. FIG. 2 is a diagram of a stimulation pulse that can be generated by the system of FIG. 1, where the stimulation pulse is shown as having a specifically negatively polarized portion and a positively polarized portion. FIG. 2 is a diagram of pulse trains of different pulse shape types that can be generated by the system of FIG. FIG. 2 is a diagram of stimulation pulses that can be generated for a single electrode group by the system of FIG. FIG. 2 is a diagram of different stimulation pulses that can be generated independently for an electrode by the system of FIG. 1. FIG. 4 is a diagram of stimulation pulses and recharge pulses that can be generated by a system for a single electrode group. It is a block diagram of the internal components of IPG of FIG. FIG. 6 is a diagram of a decreasing slope exponential pulse and an increasing slope exponential pulse generated using a stepped amplitude level. FIG. 6 is a diagram of a decreasing slope exponential pulse and an increasing slope exponential pulse generated using a stepped amplitude level. FIG. 5 is an illustration of an increasing gradient exponential pulse generated using different duration sub-pulses. FIG. 13 is a block diagram of a portion of an output stimulus circuit used in the IPG of FIG. 12, used to generate different pulse shapes. It is the figure which showed that a square pulse changes to an increase gradient exponential curve type pulse. 2 is an exemplary equivalent circuit that can be formed with a tissue electrode interface. FIG. 3 is a plan view of a handheld remote control (RC) that can be used in the nerve stimulation system of FIG. 2. FIG. 18 is a plan view of a display screen generated by the RC of FIG. 17 for providing a user with a means to select a pulse shape type. FIG. 18 is a plan view of the display screen generated by the RF of FIG. 17 representing the current pulse shape generated by the IPG of FIG. 2. It is a block diagram of the internal components of RC of FIG. FIG. 2 is a plan view of the SCS system of FIG. 1 for use with a patient.

  The description that follows relates to a spinal cord stimulation (SCS) system. However, while the invention itself is suitable for use in SCS, it should be understood that in the broadest aspect the invention is not limited thereto. Rather, the present invention can be used with any type of implantable electrical circuit that is used to stimulate tissue. For example, the present invention includes a pacemaker, a defibrillator, a cochlear stimulation applicator, a retinal stimulation applicator, a stimulation applicator formed to perform coordinated limb movement, a cortical stimulation applicator, a deep brain stimulation applicator, a peripheral device It can be used as part of a neural stimulation applicator, micro stimulation applicator, or any other neural stimulation applicator configured to deal with urinary incontinence, sleep apnea, insufficiency dislocation, headaches, and the like.

  Referring initially to FIG. 1, an exemplary SCS system 10 generally includes one or more (two in this case) implantable stimulation leads 12, an implantable pulse generator (IPG) 14, an external It includes a remote controller RC16, a clinician programmer (CP) 18, an external trial stimulus applicator (ETS) 20, and an external charger 22.

  The IPG 14 is physically connected to the stimulation lead 12 via one or more percutaneous lead wires 24. The stimulation lead 12 has a plurality of electrodes 26 arranged in a row. In the illustrated embodiment, the stimulation lead 12 is a percutaneous lead, and an electrode 26 is arranged in series along the stimulation lead 12 at the end thereof. In an alternative embodiment, the electrodes 26 can be arranged in a two-dimensional pattern on a single paddle conductor. As will be described in further detail below, the IPG 14 generates pulses to supply electrical stimulation energy to the electrode array 26 in the form of a pulsed electrical waveform (ie, a temporary series of electrical pulses) according to the stimulation parameter settings. Includes circuitry.

  The ETS 20 can be physically connected to the stimulation lead 12 via the percutaneous lead wire 28 and the external cable 30. The ETS 20 having a pulse generation circuit similar to the IPG 14 supplies electrical stimulation energy to the electrode array 26 in the form of a pulsed electrical waveform according to the set value of the stimulation parameter. The main difference between the ETS 20 and the IPG 14 is that the ETS 20 is a non-implantable device that is used on the basis of a trial. The stimulation response applied after the stimulation lead 12 is implanted and before the IPG 14 is implanted. To test. Further details of an exemplary ETS are described in US Pat. No. 6,895,280.

  The RC 16 can be used to remotely control the ETS 20 via the two-way RF communication link 32. Once the IPG 14 and the stimulation lead 12 are implanted, the RC 16 can be used to remotely control the IPG 14 via the bi-directional RF communication link 34. Such control can be programmed with different stimulus parameter settings by turning the IPG switch on and off. The IPG 14 can be operated to modify programmed stimulation parameters to actively control the characteristics of the electrical stimulation energy output by the IPG 14. CP 18 provides detailed stimulation parameters to the clinician to program IPG 14 and ETS 20 in the work room and subsequent sessions. The CP 18 can perform this function by communicating indirectly with the IPG 14 or the ETS 20 through the RC 16 via the IR communication link 36. Alternatively, CP 18 can communicate directly with IPG 14 or ETS 20 via an RF communication link (not shown). The external charger 22 is a transportable device used to charge the IPG 14 percutaneously via the inductive link 38. For brevity, details of the external charger 22 are not shown here. Details of exemplary embodiments of the external charger are described in US Pat. No. 6,895,280. When the IPG 14 is programmed and its power source is charged from the external charger 22 or replenished, the IPG 14 can function to be programmed without the RC 16 or CP 18 present.

Referring to FIG. 2, the external characteristics of the stimulation lead 12 and the IPG 14 are shown briefly.
One of the stimulation leads 12 has eight electrodes 26 (labeled E1-E8), while the other stimulation lead 12 has eight electrodes 26 (labeled E9-E16). Have). The actual number and shape of the wires and electrodes can of course vary depending on the intended application. The IPG 14 includes an outer case 40 that accommodates electronic equipment and other components (which will be described in further detail below), and a connector 42 into which the distal end of the stimulation lead 12 is fitted. Thus, the electrode 26 is electrically coupled to the electronic device in the outer case 40. The outer case 40 is made of a conductive, biocompatible material such as titanium and forms a hermetically sealed chamber to protect internal electronics from body tissues and fluids. In some cases, the outer case 40 can function as an electrode.

  As will be described in more detail below, the IPG 14 includes a pulse generation circuit that supplies electrical stimulation energy to the electrode array 26 in the form of a pulsed electrical waveform in response to stimulation parameter settings. Such a stimulation parameter can comprise an electrode combination that defines an electrode that can be switched off (zero) when it is actuated as an anode (positive), a cathode (negative), which further comprises an electrical pulse parameter. This electrical pulse parameter can be defined as the pulse amplitude (measured in milliamps or volts depending on whether the IPG 14 supplies a constant current or a constant voltage to the electrode array 26). , Pulse duration (measured in microseconds), and pulse rate (measured in pulses per second), and the pulse shape described in more detail below.

  Electrical stimulation occurs between two (or more) active electrodes, one of which can be an IPG case. Stimulation energy can be transmitted to tissue in the form of unipolar or multipolar (eg, bipolar, tripolar, etc.). Unipolar stimulation occurs when a selected one of the lead electrodes 26 is actuated with the case of the IPG 14, and the stimulation energy is transferred between the selected electrode 26 and the case. Bipolar stimulation occurs when the two lead electrodes 26 operate as an anode and a cathode, and stimulation energy is transferred between the selected electrodes 26. For example, the electrode E3 of the first conductor 12 operates as an anode, and at the same time, the electrode E11 of the second conductor 12 operates as a cathode. Tripolar stimulation occurs when three lead electrodes 26 are activated, two of which operate as anodes, the other one as a cathode, or two as a cathode and the other as an anode. For example, this is the case when the electrodes E4 and E5 of the first conductor 12 operate as anodes and the electrode E12 of the second conductor 12 operates simultaneously as a cathode.

  What is important for the present invention is that the stimulation parameters, in particular the electrical pulse parameters, further comprise a pulse shape (as opposed to a pulse magnitude including pulse amplitude and pulse width or duration). The pulse shape can be determined by the form of the pulse shape. FIGS. 3A-3I illustrate different exemplary pulse shape formats that can be generated by the IPG 14. For example, the pulse-like waveform may be a square pulse (FIG. 3A), a decreasing slope exponential curve pulse (FIG. 3B), an increasing gradient exponential curve pulse (FIG. 3C), a decreasing slope logarithmic curve pulse (FIG. 3D), or an increasing slope logarithm. A curvilinear pulse (FIG. 3E), a decreasing gradient ramp pulse (FIG. 3F), an increasing gradient ramp pulse (FIG. 3G), a trapezoidal waveform (FIG. 3H), a sinusoidal waveform (FIG. 3I), or, for example, an increasing gradient exponent curve It can be any combination of those described above, such as a mold / square pulse (FIG. 3J). The pulse shape can be defined by gradient characteristics within the same type of pulse shape. FIGS. 3K and 3L show different time constants t1-t3 (FIG. 3K) for different gradient changes, in particular decreasing gradient exponential pulses, and different time constants t1- for increasing gradient exponential pulses for the same type of pulse shape. t3 (FIG. 3L) is shown. Thus, the shape of the pulse can be changed by modifying the pulse format or modifying the slope characteristics of the pulse. (This is not simply by changing the amplitude or duration of the pulse.)

  The relationship between pulse shape and clinical effect on tissue is not well known, but different pulse shapes produce different nerve recovery commands for different sized nerve fibers, and the potential onset of nerve fiber actuation (ie It has been discovered that different temporal synchrony is produced for recovery, thereby controlling the therapeutic effect of electrical stimulation energy. For example, by using conventional techniques of nerve fibers, depending on the shape of an applied electric pulse, a primary recovery is achieved between a nerve fiber having a diameter of 8.7 μm and a nerve fiber having a diameter of 11.5 μm. It was discovered that the response was different.

  In particular, each of FIGS. 4A-4C has a diameter recovering with time corresponding to a square pulse (FIG. 4A), a decreasing slope exponential pulse (FIG. 4B), and an increasing slope exponential pulse (FIG. 4C). FIGS. 5A-5C correspond to the same square pulse (FIG. 5A), decreasing gradient exponential pulse (FIG. 5B), and increasing gradient exponential curve pulse (FIG. 5C), respectively. 2 shows a bar graph of 11.5 μm diameter nerve fibers recovering over time.

As can be inferred from FIGS. 4A and 5A, in the case of a square pulse, a relatively large number of large nerve fibers recover at the beginning of the pulse, but the number gradually decreases with time, giving a substantially uniform number of Small nerve fibers recover over the duration of the pulse. As can be inferred from FIGS. 4B and 5B, in the case of a decreasing slope exponential pulse, both a relatively large number of large and small nerve fibers recover at the beginning of the pulse, but the number gradually increases with time. Decrease.
As inferred from FIGS. 4C and 5C, the increasing gradient exponential curve pulse recovers both a relatively small number of large and small nerve fibers early in the pulse, but the number increases gradually with time.

  FIG. 6 shows the recovery of the total number of nerve fibers with a diameter of 8.7 μm versus the number of nerve fibers with a diameter of 11.5 μm over time corresponding to the application of square pulses, decreasing gradient exponential pulses, and increasing gradient exponential pulses. The ratio is shown. Based on the linear fit of the data in FIG. 6, this recovery ratio is relatively uniform over time for square pulses, and the recovery ratio increases and increases over time for decreasing gradient exponential pulses. For gradient exponential pulses, the recovery ratio decreases with time. Thus, command recovery over time for large and small nerve fibers is due to pulse shape, thereby maximizing stimulation energy output by IPG 14 in addition to correcting pulse amplitude, pulse rate, and pulse duration. It is clear from these facts that another means of exploiting is provided.

  Note that although the pulse shape format described above is described as having a single polarity (in this case, positive), the pulse shape format can have more than one polarity. Should. For example, FIG. 7 shows a pulse having a negatively polarized portion n followed by a positively polarized portion p, specifically an increasing gradient logarithmic pulse. It is believed that pulses that transition from one polarity to the next can improve fiber type discrimination. Furthermore, although the series of pulses described above (ie, pulse train) has been described as having a uniform pulse format, a single pulse train can have different pulse formats. For example, FIG. 8 shows a pulse train having a square pulse, followed by an increasing gradient ramp pulse, followed by a decreasing gradient ramp pulse. In SCS, the use of multi-pulse format trains with a single electrode combination may extend the range of sensory abnormalities by exciting different neural populations.

  It should be appreciated that a single pulse format can be generated by a group of electrodes. For example, as shown in FIG. 9, in the case of an electrode combination E1-E3 having electrodes E1 and E2 as anodes and electrode E3 as a cathode, a single incremental gradient anode gradient pulse is applied to electrodes E1 and E2. Can be generated as a group. Since the total amount of current flowing through electrodes E1-E3 must be zero (based on the storage current), a large decreasing slope cathodic ramp pulse (an amount equal to the current generated at electrodes E1 and E2) is present at electrode E3. Occurs. It should also be appreciated that different types of pulse shapes can be generated independently for electrodes configured in a single group. For example, as shown in FIG. 10, an increasing gradient anodic ramp pulse may be generated at electrode E1, while a decreasing gradient anodic ramp pulse may be generated at electrode E2. Since the total amount of current flowing through all of the electrodes E1-E3 must be zero, a cathodic square pulse is generated at electrode E3.

  While the pulse shape can be modified when used as a stimulation pulse (ie, a pulse that performs the actual stimulation), the pulse shape can also modify the recharge pulse (ie, that the DC charge travels through the tissue). It can also be corrected when used as a charge) after the stimulation pulse to prevent and avoid electrode degradation and cell damage. That is, charge is transferred through the electrode-tissue interface by current at the electrode during the stimulation period and is pulled back by the oppositely polarized current at the same electrode during the recharge period. For example, as shown in FIG. 9, when a current is supplied to the electrodes E1-E3 during the stimulation period, a recharge pulse is generated in the electrodes E1-E3 as shown in FIG. become. The shape of the recharge pulse can be modified in the same way as the stimulation pulse. In the context of the SCS, the modification of the shape of the recharge pulse is thought to produce a difference in sensory abnormalities in the same manner that the modification of the shape of the stimulation pulse produces.

  One exemplary embodiment of the IPG 14 will now be described with reference to FIG. The IPG 14 was configured to generate electrical stimulation energy according to a defined pulsed waveform having a specific pulse amplitude, pulse rate, pulse width, and pulse shape controlled by the control logic 52 of the data bus 54. A stimulation output circuit 50 is included. Control of the pulse rate and pulse width of the electrical waveform is facilitated by a timer logic circuit 56 that can have an appropriate resolution, eg, 10 μs. The stimulation energy generated by the stimulation output circuit 50 is an output given to the electrical terminals 58 corresponding to the electrodes E1-E16 via the capacitors C1-C16.

  In the illustrated embodiment, the stimulus output circuit 50 includes a plurality of independent m pairs of power sources 60 that are capable of supplying stimulus energy to the electrical terminal 58 at a particular known amount of current. One power supply 62 of each pair 60 functions as a positive (+) or anode power supply, and the other power supply 64 of each pair 60 functions as a negative (−) or cathode power supply. The outputs of each pair 60 of anode power source 62 and cathode power source 64 are coupled to a common node 66. The stimulation output circuit 50 includes a low impedance switching matrix 68 through which a common node 66 of each power supply pair 60 is coupled to any electrical terminal 58 via capacitors C1-C16.

  Thus, for example, the first anode power supply 62 (+ I1) is programmed to form a pulse having a peak amplitude of +4 mA (with a specific rate and a specific duration), and a peak amplitude of -4 mA (with the same rate and pulse). Second cathode power supply 64 (-I2) is synchronously programmed to similarly form pulses having a width), and then node 86 of anode power supply 62 (+ I1) is coupled to electrical terminal 58 corresponding to electrode E3. Furthermore, it is possible to couple the node 66 of the cathode power supply 64 (-I2) to the electrical terminal 58 corresponding to the electrode E1.

  It can be seen that each of the programmable electrical terminals 58 can be programmed to have a positive polarity (source current), a negative polarity (sink current), or no pole (no current). Further, the amplitude of the current pulse that is source or sink from a given electrical terminal 58 can be programmed to one of several distinct levels. In one embodiment, the current through each electrical terminal 58 can be individually set from 0 to ± 10 mA in steps of 100 μA within the required output voltage / current range of the IPG 14. Further, in one embodiment, the total current output by the group of electrical terminals 58 can be up to ± 20 mA (supplied between the electrodes included in the group). Further, it can be seen that each of the electrical terminals 58 can operate in a multipolar mode, for example, two or more electrical terminals are grouped together to source / sink current simultaneously. Alternatively, each of the electrical terminals 58 can operate in a unipolar mode, in which case, for example, the electrical terminal 58 is formed as a cathode (negative) and the case of the IPG 14 as an anode (positive) It is formed.

  The electrical terminals 58 can be assigned amplitude and can be divided into any number of groups up to k, which is an integer corresponding to the number of channels, where k is 4 in one embodiment. , Each channel k may have a defined pulse amplitude, pulse width, pulse rate, and pulse shape. Other channels can be implemented in a similar manner. In this way, each channel identifies which electrical terminal 58 (and its electrode) is synchronously selected to be a current source or current sink, and the pulse amplitude at each of these electrical terminals, Specify the pulse width, pulse rate, and pulse shape.

  In an alternative embodiment, rather than using a controlled independent power source, an independently controlled voltage source may be provided to provide a specific and well-known voltage stimulation pulse at electrical terminal 58. it can. The operation of this output stimulation circuit, including an alternative embodiment of a suitable output circuit for performing the same function as generating the aforementioned amplitude and width stimulation pulses, is described in US Pat. No. 6,516,227 and This is shown in more detail in US Pat. No. 6,993,384.

  From the above, it can be recognized that each shape of the stimulation pulse output by the output stimulation circuit 50 can be formed by a step-like function of the amplitude level. For example, as shown in FIG. 13A, a decreasing slope exponential pulse can be formed with a series of progressively decreasing amplitude levels, and as shown in FIG. 13B, an increasing slope exponential pulse. Can be formed with a series of progressively increasing amplitude levels. For a resolution of 10 μs and a pulse width of 100 μs, each of the pulsed waveforms shown in FIGS. 13A and 13B can be formed in 10 distinct amplitude steps. Further, as shown in FIG. 13C, the entire pulse can be formed with subpulses and subpulse durations of different amplitudes. This can give a good approximation to some waveforms even if only a few subpulses are used.

  Alternatively, the output stimulus circuit 50 does not use a stepped function of amplitude level to form a pulsed waveform, but instead provides the stimulus pulse output from each power supply 62 by one or more analog circuits. It can be formed to be molded. For example, as shown in FIG. 14, the output stimulus circuit 50 includes a plurality of different analog shaping circuits 69 (1) -69 (3) coupled to the output of each power supply 62 via a switch 71. The square output can be configured to shape one of the different types of pulse shapes selected from the respective power supply 62. For example, shaping circuit 69 (1) passes a square pulse without modification, shaping circuit 69 (2) converts the square pulse to a decreasing slope exponential pulse, and shaping circuit 69 (3) further squares. The pulses can be converted to increasing gradient exponential pulses. Each of the shaping circuits 69 (2) and 69 (3) may include at least one analog electrical component 73 having electrical characteristics (eg, capacitance or inductance), for example, correcting a time constant of the pulse shape. Thus, the pulse shape type can be adjusted to be corrected.

  In order to monitor the state of various nodes or other points 72 throughout the IPG 14, eg, supply voltage, temperature, battery voltage, and the like, the IPG 14 further includes a monitor circuit 70. The monitor circuit 70 is configured to measure electrical parameter data (eg, electrode impedance and / or electrode field potential). Measurement of electrode impedance is important because implantable electrical stimulation systems rely on the stability of the device that allows electrical stimulation pulses of known energy to be transmitted to the target excited tissue. The target tissue represents a known electrical load to which electrical energy combined with stimulation pulses is supplied. If the impedance is too great, the connector 42 and / or lead 12 (shown in FIG. 2) coupled to the electrode 26 will be open or destroyed. If the impedance is too low, somewhere in the connector 42 and / or the lead 12 may be shorted. In either case (impedance is too large or too small), IPG 14 is unable to perform its intended function.

  Measurement of electrical parameter data ideally facilitates control of pulse shape output by the output circuit 50, as will be described in detail below. Electrical parameter data can be measured using any of a variety of means. For example, measurement of electrical parameter data can be performed on a sample basis, as shown in US Pat. No. 7,317,948, at a point in time while an electrical stimulation pulse is applied to tissue, or immediately after stimulation. Can be done. Alternatively, measurement of electrical parameter data can be performed independently of electrical stimulation pulses, as shown in US Pat. Nos. 6,516,227 and 6,993,384.

  The IPG 14 further includes a processing circuit in the form of a microcontroller (μC) 74 that controls the control logic 52 of the data bus 76 and obtains status data from the monitor circuit 70 via the data bus 78. The IPG 14 further controls the timer logic 56. The IPG 14 further includes a memory 80 and an oscillator and clock circuit 82 coupled to the microcontroller 74. That is, the microcontroller 74 in combination with the memory 80 and the oscillator and clock circuit 82 includes a microprocessor system that performs program functions in accordance with a suitable program stored in the memory 80. Alternatively, for some applications, the functions provided by the microprocessor system can be performed by a machine in the appropriate state.

  The microcontroller 74 generates necessary control signals and status signals, and causes the microcontroller 74 to control the operation of the IPG 14 according to the operation program and the stimulation parameters stored in the memory 80. When controlling the operation of the IPG 14, the microcontroller 74, in combination with the control logic 52 and the timer logic 56, can individually generate stimulation pulses at the electrodes 26 using the stimulation output circuit 50, whereby each Electrodes 26 can be paired or grouped with other electrodes 26, including a single polarity case electrode, and given polarity, pulse amplitude, pulse rate, pulse width, pulse shape, and current stimulation pulse You can control and modify the channels.

  If the shape of the stimulation pulse is defined using an amplitude level step function, the microcontroller 74 combines the stimulation output circuit 50 in combination with the control logic 52 and timer logic 56 to shape the stimulation pulse. Used to generate an amplitude phase (eg, either a fixed 10 μs phase or a phase with different sub-pulse durations) at electrode 26. If the shape of the stimulation pulse is determined using the analog shaping circuit 69, the microcontroller 74 uses the control logic 52 to select the shaping circuit 69 corresponding to the desired pulse shape type via the switch 71. When the forming circuit 69 includes the analog electric circuit 73, the electric characteristics are adapted.

  In the illustrated embodiment, the microcontroller 74 modifies the pulse shape and other pulse parameters (ie, pulse amplitude, pulse width, and pulse rate) independently of each other. In a particularly beneficial embodiment, the microcontroller 74 modifies the pulse shape and other pulse parameters in a manner that is dependent on each other, i.e., the microcontroller 74 modifies the other pulse parameters in response to the modification of the pulse shape. The pulse shape can be modified in response to modification or other modification of the pulse parameters. For example, the microcontroller 74 can modify other pulse parameters in response to the modification of the pulse shape to maintain a substantially uniform charge of electrical stimulation energy. This correction ensures that the region of the pulse state (eg, by integrating the equation to define the pulse) can remain constant even if the pulse shape changes (eg, by changing the pulse amplitude or pulse width). This can be achieved with certainty.

  For example, as shown in FIG. 15, when the pulse shape changes from a square pulse shape to an increasing gradient exponential pulse shape, the pulse state region and the application of stimulation energy are reduced without modifying any of the pulse parameters. Can be made. However, as the amplitude and / or duration of the pulse increases, the region of the pulse state and the application of stimulation energy can be maintained. In the illustrated embodiment, it is RC16 that calculates the amplitude and / or duration of the pulse in response to changes in the pulse shape, as will be described in detail below. Can alternatively be implemented by the microcontroller 74.

  In an ideal embodiment, the microcontroller 74 is configured to modify the pulse shape based on the electrical properties of the tissue measured by the monitor circuit 70. That is, the electrical characteristics of the tissue that transmits electrical stimulation energy between the electrodes 26 can change the characteristics of the stimulation pulse generated by the output stimulation circuit 50, particularly the pulse shape, from the intended pulse shape (particularly the voltage source). It is desirable to adapt the actual pulse shape to the intended shape or to change the pulse shape to take into account the electrical properties of the tissue in order to achieve the desired clinical effect. .

  For example, as shown in FIG. 16, the microcontroller 74 uses an interface between the electrodes Ea and Eb and the tissue based on the tissue impedance measured by the monitor circuit 70 (that is, an electrode-tissue interface). Thus, an equivalent resistance and electric capacity circuit can be formed. By knowing the resistance value R and the capacitance values C1 and C2 in this equivalent circuit, the microcontroller 74 outputs a desired pulse shape or a pulse shape to be input to the equivalent circuit in order to achieve a desired clinical effect. Can be calculated. In one embodiment, the microcontroller 74 responds to changes in tissue electrical properties, particularly tissue impedance measured by the monitor circuit 70 (eg, due to increased fibrosis, patient movement, lead movement, etc.). The pulse shape adjustment is automatically executed. In another embodiment, the microcontroller 74 only performs this pulse shape adjustment while programming the IPG 14 for a period of time, eg, with stimulation parameters. In this case, the RC 16 can alternatively form an equivalent resistance and capacitance circuit based on the measured tissue impedance and calculate the pulse shape based on this equivalent circuit.

  The IPG 14 recovers alternating current (AC) receive coil 84 for receiving programming data (eg, actuation program and / or stimulation parameters) from the RC 16 included in the appropriately modulated carrier signal, and programming data. In order to include a charging and front telemetry circuit 86 for demodulating the carrier signal received through the AC receiver coil 84, the programming data is stored in the memory 80 or other memory element (not shown) transmitted through the IPG 14. ).

  The IPG 14 further includes a rear telemetry circuit 88 and an AC AC transmission coil 90 for sending information data read through the monitor circuit 70 to the RC 16. A characteristic of the rear telemetry of the IPG 14 is that it can check its own condition. For example, any changes that are made to the stimulation parameters are confirmed through posterior telemetry, thereby ensuring that these changes are accurately received and implemented within the IPG 14. Furthermore, by making an inquiry through the RC 16, all programmable setting values stored in the IPG 14 can be uploaded to the RC 16.

  The IPG 14 further includes a rechargeable power source 92 and a power supply circuit 94 for supplying operating power to the IPG 14. The rechargeable power source 92 can include, for example, a lithium ion battery or a lithium ion polymer battery. The rechargeable battery 92 supplies the unregulated voltage to the power supply circuit 94. The power supply circuit 94 then generates various voltages 96, some of which are adjusted and some are not adjusted as required by the various circuits located within the IPG 14. The rechargeable power source 92 is rectified AC power received by the AC receiver coil 84 (ie, other means such as an efficient AC to DC converter circuit known as, for example, an “inverter circuit”). Through, DC power converted from AC power). To recharge the power source 92, an external charger (not shown) that generates an AC magnetic field is placed in contact with or near the patient's skin located above the implanted IPG 14. . The AC magnetic field supplied by the external charger reduces the AC current in the AC receiver coil 84. Charging and front telemetry circuit 86 is used to rectify the AC current and charge power source 92 to form a DC current. AC receiver coil 84 is shown as being used to wirelessly receive communications (eg, program data and control data) and be used to charge energy from an external device, while AC receiver coil 84 is dedicated to charging. It should be appreciated that another coil such as coil 90 can be used for two-way telemetry, which can be arranged as a coil.

  As shown in FIG. 12, many of the circuits contained within IPG 14 can be implemented as a single application specific integrated circuit (ASIC) 98. This can significantly reduce the overall size of the IPG 14 and can be housed in a properly sealed and sealed case. Alternatively, most of the circuitry contained within IPG 14 can be installed on multiple digital and analog dies, as shown in US Patent Application Publication No. 2007-0038250. For example, a processor chip such as an application specific integrated circuit (ASIC) can be formed to perform processing functions with embedded software. An analog IC (AIC) can be configured to perform several operations necessary for the function of the IPG 14, including power regulation, stimulus output, application of impedance measurements and monitoring. A digital IC (DiglC) is prompted by the processor IC to control and change the stimulation level and sequence of the current output by the stimulation circuit of the analog IC to function as a primary interface between the processor IC and the analog IC. Can be formed.

It should be noted that the schematic diagram of FIG. 12 is functional and not intended to be limiting. Those skilled in the art who have received the description herein can readily configure many types of IPG circuits or equivalent circuits to perform the functions shown and described. Additional details regarding the above and other IPGs are provided in US Pat. No. 6,516,227, US Patent Publication Nos. 2003/0139781, and 2005-0267546.
The SCS system 10 as well as the IPG can alternatively utilize an implantable receiver / stimulator (not shown) coupled to the stimulation lead 12. In this case, an external power source, such as a battery, is inductively coupled to the receiver / stimulator via an electromagnetic link to operate the receiver and control circuitry embedded to command the receiver / stimulator. Housed in the controller. Data / power signals are attached transcutaneously from a transmission coil coupled with a cable placed over an implanted receiver / stimulator. The implanted receiver / stimulator receives the signal and generates a stimulus according to the control signal.

  As has been briefly described, the stimulation parameters are modified and programmed into the IPG 14 by the RC 16 and / or CP 18, thereby generating the output 26 of the electrical stimulation energy generated and output to the electrode 26 by the IPG 14. Properties can be set or changed. In the illustrated embodiment, this is accomplished by telemetry transmission commands that include stimulation parameters from IPG 14 and / or CP 18 to IPG 14. Alternatively, a no stimulation parameter command can be transmitted from the RC 16 and / or CP 18 to the IPG 14 to change the stimulation parameters stored in the IPG 14.

  Referring to FIG. 17, one exemplary embodiment of RC 16 is shown. As described above, the RC 16 can communicate with the IPG 14, the CP 18, or the ETS 20. The RC 16 includes a case 100 that houses internal components (including a printed circuit board (PCB)), a display screen 102 with illumination, and a button pad 104 that are supported on the outside of the case 100. In the illustrated embodiment, the display screen 102 is a illuminated flat panel display screen, and the button pad 104 is a thin film switch covered in a dome with metal placed over a flexible circuit, And a keypad connector directly coupled to the PCB. In any embodiment, the display screen 102 has touch screen capabilities. The button pad 104 includes a number of buttons 106, 108, 110 and 112 that can turn the IPG 14 on and off, provide stimulation parameter adjustments or settings within the IPG 14, and provide selection between screens. can do.

In the illustrated embodiment, the button 106 functions as an ON / OFF button and can actuate the IPG 14 on and off. The button 108 functions as a selection button that allows the RC 16 to switch between screen display and / or parameters.
Buttons 110 and 112 function as up / down buttons that can be operated to increase or decrease any stimulation parameters of the pulses generated by IPG 14, including pulse amplitude, pulse width, pulse rate, and pulse shape. To do. For example, the select button 108 can be activated to place the RC 16 in “pulse amplitude adjustment mode”, during which the pulse amplitude can be adjusted via the up / down buttons 110, 112, “ During the “pulse width adjustment mode”, the pulse width can be adjusted via the up / down buttons 110, 112. During the “pulse rate adjustment mode”, the pulse rate can be adjusted using the up / down buttons 110, 112. Further, during the “pulse shape adjustment mode”, the pulse shape can be adjusted via the up / down buttons 110, 112. Alternatively, an up / down dedicated button may be attached to each stimulation parameter. In addition to using the up / down buttons, any other type of actuator such as a dial, slider bar, or keypad can be used to increase or decrease the stimulation parameter.

  As an important matter for the present invention, by installing the RC 16 in the pulse shape adjustment mode, it is possible to allow the user to select the pulse shape type and gradient characteristics, and more particularly the time constant of the selected pulse type. For example, FIG. 18 shows an exemplary display screen having an identifier in the form of an icon, but this can be used as an alternative or optional means. In particular, the display screen includes a square pulse icon 113 (1), a decreasing slope exponential curve type pulse icon 113 (2), an increasing slope exponential curve type pulse icon 113 (3), a decreasing slope logarithmic curve type pulse icon 113 (4), Increasing logarithmic curve pulse icon 113 (5), decreasing gradient inclination pulse icon 113 (6), increasing gradient inclination pulse icon 113 (7), trapezoidal waveform icon 113 (8), and sinusoidal waveform icon 113 ( 9), the user can scroll and highlight (shown in the decreasing slope exponential pulse icon 113 (2)) while activating the up / down buttons 110, 112. Button 108 can be activated to select the type of pulse shape highlighted. Alternatively, rather than highlighting the pulse icon 113 by scrolling up / down using the up / down buttons 110, 112, for example, if the display screen 102 has touch screen capabilities, A check case (not shown) connected to a type of pulse shape can be ascertained by touching with a stylet or finger. Alternatively, a single button toggle switch can be used to switch between different types of pulse shapes. Within each selected type of pulse shape, the slope change characteristic can be changed by actuating the up / down buttons 110, 112 (eg, by increasing or decreasing the time constant). For example, FIG. 19 shows that when the up / down buttons 110, 112 are activated to change the time gradient of the pulse (the previous pulse shape is shown in phantom), the current pulse shape (in this case, the decrease FIG. 6 shows an exemplary display screen representing (gradient exponential pulses). In any embodiment, the shape / cycle mode can automatically indicate different pulse shapes during one cycle (eg, changes every 3-5 seconds), which allows the user to make many different pulses. The shape can be recognized quickly. When the user recognizes the optimal stimulus, the user can activate a button to select the pulse shape represented at that time. The pulse shape can be displayed to the user when presented, or alternatively can be in a state that is always visible to the user.

  Referring to FIG. 20, the internal components of an exemplary RC 16 are shown. The RC 16 generally outputs the stimulation parameters to the processor 114 (eg, a microcontroller), an operating program executed by the processor 114 and memory 116 for storing stimulation parameters, input / output circuitry, and specifically the IPG 14. A telemetry circuit 118 for receiving status information from the IPG 14 and an input for receiving stimulus control signals from the button pad 104 and transmitting the status information to the display screen 102 (shown in FIG. 18). / Output circuit 120 is included. Although not shown here for brevity, the processor 114 not only controls other functions of the RC 16, but also supports pulse amplitude, pulse width, pulse rate, and user button pad 104 operation. A plurality of stimulation parameter setting values for determining a pulse shape to be generated are generated. These new stimulation parameter settings are transmitted to the IPG 14 via the telemetry circuit 118, thereby adjusting the stimulation parameters stored in the IPG 14 and / or programming the IPG 14. Telemetry circuit 118 can be used to receive stimulation parameters from CP 18. Further details of RC16 functionality and internal components are described in US Pat. No. 6,895,280.

  As described above with respect to IPG 14, the pulse shape and other pulse parameters in the illustrated embodiment are modified independently of each other. In this case, the processor 114 is configured to define the pulse shape and other pulse parameters at each stimulation parameter setting that is independent of each other. However, if it is advantageous to modify the pulse shape and other pulse parameters in a manner that is dependent on each other, the processor 114 may set other pulse parameters, for example, depending on the setting of one pulse shape. The pulse shape and other pulse parameters are determined so that the electric charge is uniform between the set of stimulation parameters so that each stimulation parameter setting value is dependent on each other. Can do.

  As described briefly above, after implantation, modifying and programming the stimulation parameters in the memory of the programmable IPG 14 can be performed by the physician or clinician using the CP 18 and directly with the IPG 14. Communicate or communicate indirectly with the IPG 14 via the RC 16. That is, the CP 18 can be used by a physician or clinician to modify the operating parameters of the electrode array 26 near the spinal cord. As shown in FIG. 1, the overall appearance of the CP 18 is the same as a laptop personal computer (PC) and, in fact, is appropriately configured to include a directional programming device and the functions described herein. Can be implemented using a PC programmed to perform. Thus, the program methodology can be accomplished by executing software instructions contained within the CP 18. Alternatively, such program methodologies can be implemented using firmware or hardware. In any case, the CP 18 actively controls the characteristics of the electrical stimulation generated by the IPG 14 (or ETS 20), determines optimal stimulation parameters based on patient feedback, and then optimizes stimulation. Allows IPG 14 (or ETS 20) to be programmed with parameters. Thus, the functionality of CP18 is similar to that of RC18, except that it greatly simplifies the program of optimal stimulus parameters. Further details of CP and other programming devices are shown in US Pat. Nos. 6,393,325 and 6,909,917.

  Having described the structure and function of the SCS system 10, a method of embedding and operating the system 10 will now be described. Referring to FIG. 21, the stimulation lead 12 is implanted in the spinal column 142 of the patient 140. The preferred location of the stimulation lead 12 is the location adjacent to the stimulated spinal cord region, i. The ETS 20 is coupled to the stimulation lead 12 via a percutaneous lead wire 28 and an external cable 30 (not shown in FIG. 21) and operates to supply electrical stimulation energy to the electrode 26 according to a defined waveform. be able to. The pulse parameters of the waveform (including pulse amplitude, pulse duration, pulse rate, and pulse shape) can be modified under the control of the CP 18 so that the electrical stimulation energy delivered from the electrode 26 to the tissue The characteristics can be changed to test the efficacy of the stimulus applied to the patient 140. The CP 18 can be used to program the optimal stimulus parameters into the ETS 20.

  After the trial period is over (typically 1-2 weeks), the IPG 14 is implanted in the patient 140 and coupled to the stimulation lead 12. Because there is no space near the location where the stimulation lead 12 exits the spinal column 140, the IPG 14 is typically implanted in a surgically formed pocket either in the abdomen or at the top of the hip. Of course, the IPG 14 can also be implanted in other locations on the patient's body. The lead wire 24 helps to install the IPG 14 away from the point where the stimulation wire 12 exits. In the same manner as briefly described above with respect to ETS 20, IPG 14 can be operated and programmed with optimal stimulation parameters under the control of CP 18. Under patient control, the RC 16 can then be used to select a stimulation program or can be used to modify stimulation parameters previously programmed into the IPG 14 to change treatment.

  While specific embodiments of the present invention have been shown and described, it should be understood that the invention is not limited to the preferred embodiments and various changes and modifications will occur to those skilled in the art. Obviously, this can be done without departing from the spirit and scope of the present invention. Accordingly, the present invention is intended to include alternatives, modifications, and equivalents, which may be included within the spirit and scope of the present invention as defined by the claims.

Embodiments of the present invention will be described below.
Embodiment 1 One or more electrical terminals configured to be coupled to one or more stimulation leads;
An output stimulation circuit capable of outputting electrical stimulation energy to the one or more electrical terminals according to a defined waveform;
A control circuit configured to modify a pulse shape of the defined waveform corresponding to a user input, thereby changing a characteristic of the electrical stimulation energy output to the one or more electrodes;
An implantable electrical tissue stimulation system comprising:
(Embodiment 2) The electrical stimulation according to Embodiment 1, wherein the control circuit is configured to modify the pulse shape by selecting one of a plurality of different types of pulse shapes. system.
(Embodiment 3) The electrical stimulation system according to Embodiment 2, wherein the different types of pulse shapes include a square pulse and an exponential curve type pulse.
(Embodiment 4) The different types of pulse shapes include at least two of a square pulse, an exponential curve pulse, a logarithmic curve pulse, a gradient pulse, a trapezoidal pulse, and a combination thereof. The electrical stimulation system according to Embodiment 2.
(Embodiment 5) The electrical stimulation system according to Embodiment 2, wherein the different types of pulse shapes include a decreasing gradient pulse and an increasing gradient pulse.
(Embodiment 6) The electrical stimulation system according to embodiment 5, wherein the decreasing gradient pulse is a decreasing gradient exponential curve type pulse, and the increasing gradient pulse is an increasing gradient exponential curve type pulse.
(Embodiment 7) The electrical stimulation system according to Embodiment 5, wherein the decreasing gradient pulse is a decreasing gradient linear gradient pulse, and the increasing gradient pulse is an increasing gradient linear gradient pulse.
(Embodiment 8) The electrical stimulation system according to Embodiment 1, wherein the control circuit is formed to correct the pulse shape by adjusting a time constant of the pulse shape.
(Embodiment 9) The electrical stimulation according to Embodiment 1, wherein the control circuit is configured to modify the pulse shape of the predetermined waveform and other pulse parameters independently of each other. system.
(Embodiment 10) The electrical stimulation system according to embodiment 1, wherein the control circuit is configured to modify the pulse shape and at least one other pulse parameter in a manner dependent on each other. .
Embodiment 11 The control circuit is configured to modify the at least one other pulse parameter in response to the modification of the pulse shape to maintain a substantially uniform application of the electrical stimulation energy. The electrical stimulation system according to embodiment 10, wherein:
Embodiment 12 further includes a monitor circuit configured to measure one or more electrical characteristics of the tissue, wherein the control circuit is based on the measured one or more electrical characteristics, The electrical stimulation system of embodiment 1, wherein the electrical stimulation system is configured to modify a pulse shape.
Embodiment 13 The control circuit according to Embodiment 12, wherein the control circuit is configured to correct the pulse shape in response to the measured change in one or more electrical characteristics. Electrical stimulation system.
Embodiment 14 The output stimulation circuit includes a plurality of different analog shaping circuits, and the control circuit is configured to modify the pulse shape by selecting one of the different analog shaping circuits. The electrical stimulation system of Embodiment 1 characterized by the above-mentioned.
(Embodiment 15) According to Embodiment 1, wherein the control circuit is configured to correct the pulse shape by adjusting a characteristic of at least one analog electrical component in the output stimulation circuit. The electrical stimulation system described.
(Embodiment 16) The pulse waveform is formed by a stepped function of amplitude level or sub-pulse duration, and the control circuit adjusts the amplitude level or sub-pulse duration to correct the pulse shape. The electrical stimulation system according to the first embodiment, which is configured as follows.
Embodiment 17 The electrical stimulation system of embodiment 1, further comprising a stimulation lead having at least one electrode electrically coupled to the one or more electrical terminals.
(Embodiment 18) The electrical stimulation system according to Embodiment 1, further comprising a memory capable of storing parameters for determining the pulse shape.
Embodiment 19 The electrical stimulation system according to Embodiment 1, further comprising a telemetry circuit capable of receiving a command from an external programmer wirelessly in order to modify the pulse shape.
(Embodiment 20) Embodiment 1 further comprising a case for housing one or more electrical terminals, an output stimulation circuit, wherein the control circuit is housed to form a neural stimulation applicator. Electrical stimulation system.
(Embodiment 21) The electrical stimulation system according to embodiment 20, wherein the nerve stimulation applicator is an implantable type.

(Embodiment 22) A user interface capable of receiving input from a user;
A processor configured to generate a plurality of stimulation parameter settings defining a plurality of different pulse shapes in response to the user input;
An output circuit configured to transmit the plurality of stimulation parameter settings to the neural stimulation applicator;
A programmer for an electrical tissue stimulation applicator characterized by comprising:
Embodiment 23 The programmer according to embodiment 22, wherein the plurality of different pulse shapes include a plurality of different types of pulse shapes.
Embodiment 24 The programmer according to embodiment 23, wherein the different types of pulse shapes include square pulses and exponential curves.
Embodiment 25 The different types of pulse shapes include at least two of a square pulse, an exponential curve pulse, a logarithmic curve pulse, a gradient pulse, a trapezoidal pulse, and a combination thereof. The programmer according to 23.
Embodiment 26 The programmer according to embodiment 23, wherein the different types of pulse shapes include a decreasing gradient pulse and an increasing gradient pulse.
Embodiment 27 The programmer according to embodiment 26, wherein the decreasing gradient pulse is a decreasing gradient exponential pulse and the increasing gradient pulse is an increasing gradient exponential pulse.
Embodiment 28 The programmer according to embodiment 26, wherein the decreasing gradient pulse is a decreasing gradient linear gradient pulse, and the increasing gradient pulse is an increasing gradient linear gradient pulse.
Embodiment 29 The programmer according to embodiment 23, wherein the plurality of different types of pulse shapes include a plurality of pulse shapes of the same type but having different time constants.
Embodiment 30 The programmer according to embodiment 23, wherein the processor is formed to determine the pulse shape and other pulse parameters independently of each other at each stimulation parameter setting value.
Embodiment 31 The programmer according to embodiment 23, wherein the processor is configured to determine the pulse shape and other pulse parameters at respective stimulation parameter setting values according to each other.
Embodiment 32 The processor is configured to determine at least one of the other pulse parameters corresponding to the definition of the pulse shape, and is substantially uniform between the respective stimulation parameter settings. 32. The programmer of embodiment 31, wherein the charge is maintained.
Embodiment 33 The programmer of embodiment 21, wherein the plurality of different types of pulse shapes are determined based on one or more measured electrical properties of the tissue.
Embodiment 34 The programmer of embodiment 33, wherein the plurality of different types of pulse shapes are defined in response to changes in the one or more measured electrical characteristics.
Embodiment 35 The user interface includes an actuating device, and the processor is configured to generate the plurality of stimulation parameter setting values in response to actuation of the actuating device. A programmer according to embodiment 23.
Embodiment 36 The programmer according to embodiment 35, wherein the processor is formed to define the plurality of different pulse shapes in response to operation of the actuator.
(Thirty-third Embodiment) The programmer according to the twenty-third embodiment, wherein the output circuit is a telemetry circuit capable of wirelessly transmitting the plurality of stimulation parameter setting values to the neural stimulation applier.

(Embodiment 38) placing one or more electrodes proximal to the patient's tissue;
Supplying electrical stimulation energy to the tissue from the one or more electrodes according to a defined waveform;
Modifying the pulse shape of the determined waveform in response to a user input, thereby changing the characteristic of the electrical stimulation energy delivered to the tissue from the one or more electrodes. How to treat the patient.
Embodiment 39 The method of embodiment 38, wherein the pulse shape modification comprises selecting one of a plurality of different pulse shape types.
Embodiment 40 The method of embodiment 39, wherein the different types of pulse shapes comprise square pulses and exponential curves.
Embodiment 41 The different types of pulse shapes include at least two of a square pulse, an exponential curve pulse, a logarithmic curve pulse, a gradient pulse, a trapezoidal pulse, and a combination thereof. 40. The method according to 39.
Embodiment 42 The method of embodiment 39, wherein the different types of pulse shapes comprise a decreasing gradient pulse and an increasing gradient pulse.
Embodiment 43 The method of embodiment 42, wherein the decreasing gradient pulse is a decreasing gradient exponential pulse and the increasing gradient pulse is an increasing gradient exponential pulse.
Embodiment 44. The method of embodiment 42, wherein the decreasing gradient pulse is a decreasing gradient linear ramp pulse and the increasing gradient pulse is an increasing gradient linear gradient pulse.
Embodiment 45 The method of embodiment 38, wherein the modification of the pulse shape includes adjusting a time constant of the pulse shape.
Embodiment 46. The method of embodiment 38, wherein the pulse shape and other pulse parameters of the defined waveform are modified independently of each other.
Embodiment 47 The method of embodiment 38, wherein the pulse shape of the defined waveform and at least one other pulse parameter are modified depending on each other.
Embodiment 48 The embodiment wherein the at least one other pulse parameter is modified in response to the modification of the pulse shape to maintain a substantially uniform charge of the electrical stimulation energy. 48. The method according to 47.
Embodiment 49 further comprising measuring one or more electrical properties of the tissue, wherein the pulse shape is modified based on the measured one or more electrical properties. 38. The method according to 38.
Embodiment 50 The method of embodiment 48, wherein the pulse shape is modified in response to a change in the measured one or more electrical characteristics.
Embodiment 51 The method according to Embodiment 38, wherein the tissue is spinal cord tissue.

DESCRIPTION OF SYMBOLS 10 SCS system 12 Stimulation lead 14 Implantable pulse generator 16 External remote controller 18 Clinician programmer 20 External trial stimulus applicator 22 External charger 24 Transcutaneous lead wire 26 Electrode 28 Transcutaneous lead wire 30 External cable 40 Outer case

Claims (17)

  1. One or more electrical terminals (58) coupled to one or more stimulation leads (12);
    According a defined neural stimulation waveform is configured electrical nerve stimulation energy including a plurality of pulses so as to output the one or more electrical terminals (58) having a pulse shape, and the pulse shape, said plurality An output stimulus circuit that is not a change in pulse shape, but a change in pulse shape and not a change in pulse width or duration, in terms of the amplitude, width or duration of each of the pulses of 50),
    In response to a user input, the pulse shape of the defined neural stimulation waveform and at least one other pulse parameter that depend on each other are modified and output to the one or more electrical terminals (58). A region of each of the plurality of pulses when the pulse shape is changed before and after the correction of the pulse shape corresponding to the correction of the pulse shape corresponding to the correction of the pulse shape. and so that the pulse to maintain a substantially uniform charge by keeping constant, said at least one other control circuit configured to modify the pulse parameters (74),
    An implantable electrical nerve stimulation system (10) for supplying therapeutic electrical nerve stimulation energy to neural tissue, comprising:
  2.   And further comprising a monitor circuit (70) configured to measure one or more electrical characteristics of the tissue, wherein the control circuit (74) is configured to generate the pulse based on the measured one or more electrical characteristics. The electrical nerve stimulation system (10) of claim 1, wherein the electrical nerve stimulation system (10) is configured to modify a shape.
  3.   The electrical nerve stimulation of claim 2, wherein the control circuit (74) is configured to modify the pulse shape in response to the measured change in one or more electrical characteristics. System (10).
  4.   The electrical nerve stimulation system of claim 1, wherein the control circuit (74) is configured to modify the pulse shape by selecting one of a plurality of different types of pulse shapes. (10).
  5.   The electrical nerve stimulation system (10) of claim 4, wherein the different types of pulse shapes include square pulses and exponential curves.
  6.   5. The different types of pulse shapes include at least two of square pulses, exponential curve pulses, logarithmic curve pulses, ramp pulses, trapezoidal pulses, and combinations thereof. Electric nerve stimulation system (10).
  7.   The electrical nerve stimulation system (10) of claim 4, wherein the different types of pulse shapes include decreasing gradient pulses and increasing gradient pulses.
  8.   The electrical nerve stimulation system (10) of claim 7, wherein the decreasing gradient pulse is a decreasing gradient exponential pulse and the increasing gradient pulse is an increasing gradient exponential pulse.
  9.   The electrical nerve stimulation system (10) according to claim 7, wherein the decreasing gradient pulse is a decreasing gradient linearly inclined pulse, and the increasing gradient pulse is an increasing gradient linearly inclined pulse.
  10.   The output stimulus circuit (50) includes a plurality of different analog shaping circuits (69), and the control circuit (74) selects the one of the different analog shaping circuits (69) to thereby change the pulse shape. The electrical nerve stimulation system (10) of claim 1, wherein the electrical nerve stimulation system (10) is configured to modify.
  11.   The control circuit (74) is configured to modify the pulse shape by adjusting a characteristic of at least one analog electrical component in the output stimulation circuit (50). Electrical nerve stimulation system (10) according to
  12.   The defined neural stimulation waveform is formed by a stepped function of amplitude level or sub-pulse duration, and the control circuit (74) modifies the pulse shape by adjusting the amplitude level or sub-pulse duration. The electrical nerve stimulation system (10) according to claim 1, wherein the electrical nerve stimulation system (10) is configured as follows.
  13.   The electrical nerve of claim 1, further comprising a stimulation lead (12) that supports at least one electrode (26) that is electrically coupled to the one or more electrical terminals (58). Stimulation system (10).
  14.   The electrical nerve stimulation system (10) of claim 1, further comprising a memory (80) capable of storing parameters defining the pulse shape.
  15.   The electrical nerve stimulation of claim 1, further comprising a telemetry circuit (86) capable of wirelessly receiving commands from an external programmer (16, 18) to modify the pulse shape. System (10).
  16.   Further comprising a box (40) containing one or more electrical terminals (58), an output stimulation circuit (50) and a control circuit (74) to form a neural stimulation applier (14). The electrical nerve stimulation system (10) according to claim 1, characterized by:
  17.   The electrical nerve stimulation system (10) of claim 16, wherein the nerve stimulation applicator (14) is implantable.
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